Haishengsu as an adjunct therapy to conventional chemotherapy in patients with non-small cell lung cancer: A pilot randomized and placebo-controlled clinical trial

Objective: To investigate the effect of Haishengsu, an extract from Tegillarca granosa, on non-small cell lung cancer as an adjunct to conventional chemotherapy. Designs/settings: Randomized, double-blind, placebo-controlled trial was conducted in 83 patients. The Haishengsu (n = 42, 2.4 mg Haishengsu in 250 ml normal saline, iv, for 15 days) and the placebo group (n = 41, 250 ml normal saline, iv) were also treated with two cycles (28 days for each cycle) of conventional chemotherapy consisting mitomycin, vindesine and cisplatin. Results: The curative effect of conventional chemotherapy was observed in 62% of Haishengsu group patients and in 39% in of the placebo group patients (P = 0.04, RR 1.59, 95% Cl: 1.01-2.49). Improvement in Karnofsky performance status scores was seen in 66.7% of Haishengsu group patients and in 17.1% of the placebo group patients (P < 0.01, RR 3.63, 95%CI: 1.77-7.41). The ratio of patients with no or only mild gastrointestinal reaction in the Haishengsu and the placebo group was 83.3% and 39.0%, respectively (P < 0.01, RR 2.13, 95% Cl: 1.42-3.20). Conclusions: This study suggests that Haishengsu may be an effective adjunct therapy to the conventional chemotherapy for non-small cell lung cancer. The short-term therapeutic effect of chemotherapy may be improved and the chemotherapy-induced nausea or vomiting may be reduced by concurrent Haishengsu administration. Crown Copyright (C) 2008 Published by Elsevier Ltd. All rights reserved.